Good day. Welcome to the Foamix Pharmaceuticals phase III data call. Today's conference is being recorded. At this time, I'll turn the conference over to Michael Wood of LifeSci Advisors. Please go ahead, sir.
Thank you, Derek. Good morning, everyone. Thank you for joining us. Welcome to the Foamix conference call. Leading today's call will be David Domzalski, Chief Executive Officer of Foamix, Dr. Iain Stuart, Senior Vice President of R&D, and Ilan Hadar , Chief Financial Officer of the company, will also be on the call and will be available to answer questions during the Q&A session. After the market close yesterday, Foamix issued a press release summarizing the top-line results from the recently completed confirmatory phase III clinical trial of FMX101 for the treatment of moderate to severe acne. If you did not yet receive the press release, it's available on the investor relations page of the Foamix website, foamix.com. There are also slides accompanying this call. They can be viewed by logging on to the webcast.
The link is on the investor page of the corporate website under upcoming events. The link is also in the press release on page two. This call is being recorded. The replay will be available on the company's website. Before we begin the formal remarks, I want to remind you that some of the information in the news release and on this conference call contain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict, or words that express and reflect optimism, satisfaction with current progress, prospects or projections, as well as words such as believe, intend, expect, plan, anticipate, and similar variations identify forward-looking statements, but their absence does not necessarily mean that a statement is not forward-looking. Such forward-looking statements are not a guarantee of performance. The company's actual results could differ materially from those contained in such statements.
Several factors that could cause and/or contribute to such differences are described in detail in Foamix's filings with the SEC. These forward-looking statements speak only as of the date of the press release and today's conference call. The company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the circumstances after the date of this call. With that, I'd like to turn the call to the CEO of Foamix. Dave, please go ahead.
Thank you, Michael. Good morning, everyone, and thank you all for joining our call today as we share the exciting results from our FMX101 4% minocycline foam confirmatory phase III clinical trial, known as Study FX2017-22 or simply Study 22. This is a very exciting moment for all of us here at Foamix. By now, hopefully you have had a chance to read the press release we issued last night. I am very pleased to report that Study 22 successfully met both its co-primary endpoints and that these results were achieved with a high magnitude of therapeutic effect and statistical significance. The safety profile of FMX101 continues to look excellent. Recall that this clinical trial was designed as a confirmatory phase III study for FMX101 in moderate-to-severe acne.
Following the completion of the prior phase III studies with this drug candidate in 2017, which are Study 04 and Study 05, we held a Type B meeting with the FDA. We agreed with the agency at that time that statistically significant findings from a third study would constitute replication of the Study 05 results and would be sufficient for establishing an efficacy claim for FMX101. We now believe these data, these new data we are announcing today, meet this requirement. Our goal is to move forward with an NDA filing to seek approval for FMX101 in the U.S. Let me begin with a review of the study design. This is outlined on slide four in the slide presentation. Study 22 is a double-blind, randomized, vehicle-controlled, phase III trial that enrolled 1,507 patients with moderate-to-severe acne at 89 sites across the U.S.
Patients were randomized one to one to receive either FMX101 minocycline foam at a 4% concentration or vehicle foam for a 12-week period. Patients applied active drug or vehicle themselves once daily. The study was designed with two co-primary efficacy endpoints. First, the absolute change from baseline in the number of inflammatory lesions. Second, treatment success as measured by Investigator Global Assessment or IGA score, where success was defined as an IGA score of zero or one, which is clear or almost clear, and at least a 2-grade improvement or decrease from baseline. In order to be included in the study, patients were required to have between 20 and 50 inflammatory acne lesions and 25 to 100 non-inflammatory lesions. Patients enrolled had either moderate or severe disease, defined as a grade 3 or 4 on the IGA six-point scale that we used.
Because of quality issues identified at one center, 19 subjects were excluded from the intent to treat population. The ITT, for the purposes of the efficacy analysis, comprised of 1,488 patients. The decision to exclude these patients was made well before we received the top-line data. The patient demographics and baseline characteristics are presented here on the next slide. For these data, as well as the efficacy and safety data that I will discuss on the following slides, we are presenting it side by side with the results from Study 05 for comparison purposes. In Study 22, the baseline mean inflammatory lesion counts were 30.7 and 30.8 for the FMX101 and vehicle treatment groups, respectively. The baseline non-inflammatory lesion counts were 49.7 and 49.6 for active treatment and vehicle groups respectively as well.
In the active treatment arm, 84% of patients had an IGA score of 3, which is considered moderate acne at baseline, and 16% had a score of 4, which is severe acne. This compares with 83.5% of patients in the vehicle group having a baseline score of 3 and 16.5% with a score of 4. The important thing to take away from this slide was that the patient demographics and baseline data were very similar between Study 22 and our previous Study 05 trial. The proportion of patients with severe disease appeared slightly higher in both the active and vehicle treatment groups of Study 22 compared with the previous study. The efficacy results on the first co-primary endpoint are shown here on the left-hand chart of Slide six.
Patients in the FMX101 active treatment group achieved a 16.93 mean absolute reduction in the number of inflammatory lesion count from baseline to week 12. This compares with a 13.4 mean absolute reduction in the number of inflammatory lesion counts for the vehicle group. This result was highly statistically significant with a P value of less than 0.0001. The efficacy results on this endpoint from the prior phase III Study 05 are shown on the right. You can see the differences between active treatment and vehicle were of approximately the same magnitude across both studies. The data for the second co-primary endpoint, treatment success based on IGA score, are presented on Slide seven. You can see that in Study 22, 30.8% of patients in the FMX101 treatment arm achieved treatment success compared to 19.6% of those in the vehicle arm.
Once again, this result was highly statistically significant with a P value less than 0.0001. For this endpoint, there appears to be a considerable difference to what was demonstrated in Study 05. You can see in the prior phase III study, the proportions of patients achieving treatment success were 14.7% and 7.9% for the active FMX101 and vehicle arms respectively. There are clear limitations in comparing data across our two studies being presented, and it would be speculative to suggest any definitive reasons for the different results. However, as we have communicated many times over the past several quarters, we have dedicated significant resources in clinical investigator training and operational management at the site level in partnership with our CRO.
These efforts were led by Dr. Iain Stuart, our senior vice president of research and development, and I want to personally recognize Iain and his entire team in the U.S. and Israel for their exceptional work. The charts here on Slide eight show the percentage change in inflammatory lesion counts at weeks three, six, nine, and 12. This was a key secondary endpoint in both studies. At week 12, there was a 56% reduction in inflammatory lesion counts for FMX101 compared to a 43% reduction for vehicle. You can also see that in Study 22, for all time points, beginning at week three, there was a highly statistically significant percentage reduction in lesion counts for active FMX101 treatment compared with vehicle. Again, the P value at all time points was less than 0.0001. For comparison purposes, the results from Study 05 are presented on the right.
The safety results from Studies 22 and 05 are summarized on Slides nine and 10. Overall, FMX101 appeared to be generally safe and well-tolerated, and the safety data appear consistent with prior studies with this drug, including Study 05. The non-cutaneous treatment emergent adverse events that occurred at an incidence of at least 1% of patients in Studies 22 and Study 05 are listed in the table on Slide nine. The most common systemic adverse event was upper respiratory tract infection. The overall incidence of this was 6.4% in Study 22 and 6.1% in Study 05. No treatment-related serious adverse events were reported in either study. In Study 22, cutaneous treatment emergent adverse events in the FMX101 treatment group were few. Most were mild, including pruritus, dermatitis, swelling, hyperpigmentation, and discoloration. The actual number of events for each listed on this slide was only one per condition.
That is it, out of nearly 740 patients in the active group. In total, nine subjects in Studies 22 and 05 discontinued treatment due to a treatment-emergent adverse event, including five in the FMX101 treatment group and four in the vehicle treatment group. Going to slide 11 to summarize. The data from Study 22 showed strong statistically significant disease improvement of FMX101 compared with vehicle for both co-primary endpoints of absolute reduction of inflammatory lesions and IGA treatment success at week 12. These data are consistent with our prior phase III study, Study 05. FMX101 appears to be well-tolerated with an excellent safety profile. In both Studies 22 and 05, treatment-emergent adverse events were few in type and frequency, thus were mild in severity. No treatment-related serious adverse events were reported.
Finally, before we open the call for questions, on behalf of Foamix, I would like to thank the patients, clinical investigators, and the support staffs for participating in this clinical trial. I also want to thank all my fellow colleagues at Foamix for their tremendous work and dedication. A trial such as this requires enormous effort from all those involved, and we are certainly very delighted with the outcome. With that, I'd like to turn the call back to the operator to open the line for Q&A. Operator?
Thank you, sir. Ladies and gentlemen, if you'd like to ask a question over your phone at this time, please signal by pressing star one on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, that is star one to ask a question. We'll move to our first question from Ken Cacciatore of Cowen and Company. Please go ahead.
Hey, congratulations, guys, on the data. Very happy for everyone. Dave, since the development of FMX101, the market's shifted a little bit. Wondering if you could talk about some of the dynamics in the acne market in terms of pricing and managed care, and then maybe where this would fit into the paradigm and some thoughts about maybe an analog for us to compare it to so we could get some perspective around the market opportunity. Thanks.
Sure. Thanks, Ken. Of course, this market, not really unlike many markets in the pharmaceutical arena, is constantly changing. It's fluid. This market continues to be a large and sizable marketplace. Script volume, which is one that we really focus on, is around 5 million scripts. Just looking at branded therapies, roughly 1 million oral antibiotic branded prescriptions are written a year. About 4 million branded topical prescriptions. We continue to look at this as a large market, a multi-billion dollar category. Of course, there's been changes. There have been products that have recently been genericized, but also we have new products that hopefully will be entering the market, including ours, if we are successful in an ultimate NDA approval down the line. We've done a lot of research in the space. There's significant unmet needs. We've talked about the continued opportunity of a product like ours.
I think this data reflects the fact that we've shown strong efficacy. We have an excellent safety profile. We've repeatedly talked over the several quarters in the last few years about how this marketplace really is yearning for safe and efficacious new products for patients. We believe that we hopefully will have a product that will get approved, and we'll be able to address that. If you take a look at some of the leading therapies, whether it's the dapsone molecule, the combination adapalene benzoyl peroxide product, these are leading therapies in the category, large prescription volumes, large revenue generated.
We know that the oral antibiotic space is a space we believe we can take market share from that with a product like ours that we've been able to demonstrate good efficacy and an excellent safety profile hopefully without a lot of the systemic side effects that are associated with those products. We've always said that FMX101, if approved, has the ability to compete both within the oral antibiotic category as well as the topical category. I think the results that we saw from Study 22 just further strengthens our conviction around that. Hopefully that provides some good color, Ken, for you.
It does. Thanks. Congrats again.
Thank you.
Thank you. Our next question comes from Vamil Divan of Credit Suisse.
Hi. Great. Thanks for taking the question. Just a couple. One, you mentioned this one center where you had issues and you've excluded those patients. Can you just provide a little more detail on that and the decision to remove those even though it was done, as you said before, you saw any of the top-line data? Maybe building off of Ken's question on the commercial side, I guess based on what you see with the data here, how do you envision payer acceptance of the product? Would you envision a certain number of generics that patients would need to go through before they can use this? Maybe you can just kind of give us a sense of how you see the sort of treatment paradigm evolving, assuming this makes it to the market.
Hi, Vamil. I'll ask that Iain address the first question about the centers. Iain.
Yeah. Hi. Thanks for the question, Vamil. Yeah. In relation to the 19 subjects, how these were identified during our regular clinical site monitoring activities earlier this year, well in advance of the top-line data we communicated last night. I can't go, obviously because of the sensitivity of this issue, into specifics, but it really revolves around data integrity and principal investigator oversight on the study. We identified this early, and we took decisive action when we became aware of the issues. This was captured specifically in our statistical analytical plan prospectively and was handled way before we went anywhere near database lock and unblinding.
Thanks, Iain. Vamil, to further comment on the reimbursement landscape and our product. A couple thoughts. As we've shared repeatedly, we've done a fair amount of market research. We've not obviously determined or locked in on a potential price for our product, and we won't do that for some time, as you can appreciate. We'll continue to conduct the research, the research has been very positive from the payer category. We've always said that we believe that this is a product that would be at a significant discount to the branded oral antibiotic therapies and in the range of the leading topical therapies. Our objective is to do what is necessary to make sure patients have access to our product if approved. That's obviously our goal.
We will work with payers, we will work with patient-based organizations to do whatever's necessary to ensure that our product is accessible to patients. We continue to feel very good about that. We believe our product, if approved, can address unmet needs for patients and for caregivers. We believe we have a very good value proposition for the payer base. Once again, I think our results from Study 22 reinforce that position that we have.
Okay. Thanks so much. Congrats on the news. Thanks.
Got it. Yeah, thanks.
Thank you. We'll next move to Rom Selvaraju of H.C. Wainwright. Please go ahead.
Hi there. This is Julian on for Rom. Congrats on the data. My first question is, I was just curious if you were surprised by how low the discontinuation rate was for this trial, I guess particularly in light of the trial size.
No, I think it's completely consistent with our Study 04 and Study 05 at approximately 13% discontinuation rate. We're satisfied with that.
Okay, great. Thanks for that. Moving on, would you characterize the safety profile of FMX101 as comparable across all three pivotal studies? If not, were there any, I guess, notable differences between those studies?
No, I think broadly speaking, they were comparable. As Dave outlined during the presentation slides, the most frequent treatment-emergent adverse event was upper respiratory tract or nasopharyngitis, commonly known as the common cold. I think that was consistent across Study 04, Study 05, and Study 22.
Okay. My last question, just looking forward, how long is it likely to take to assemble the materials necessary to file an NDA? What might the commercial infrastructure around FMX101 look like, and how long might that take to build?
Sure. I'll address those questions. Regarding the timing of an NDA filing, we've completed a vast majority of the work to date. Our goal is to file an NDA by the end of this year, and we're working diligently to achieve that goal. As mentioned previously, we already had our pre-NDA meeting with the FDA earlier this year. Obviously, a key component will be waiting until we get the final clinical study report from Study 22. As you can appreciate, that takes a little bit of time to get all of that. We've got other components of the filing that we're working on. We've been doing this for some time. Again, our goal is to file an NDA by the end of the year. We'll keep everybody posted along the way. Regarding the commercial infrastructure, I'll offer a couple thoughts.
One is, we'll spend the next several months conducting a lot of work around healthcare provider education and awareness. That will include several components, publications, congress and convention work. We'll be presenting our data in posters, et cetera. Obviously continuing to work with the healthcare provider arena as well as with the payer base. In terms of sales force size, I know this is a question that's come up often. We've always said that a sales force size would probably be somewhere in the 50 to 100 colleague range. That does not change. There's roughly around 15,000 active dermatologists in the U.S. Of that, about a third of them generate about 70%-80% of the prescription volume and see the majority of the patients.
That gets you a commercial footprint in that 50 to 100 representative range, and that's fairly consistent with what you see with other organizations in the category. Could that be a little bit higher, a little bit lower? It could. I think, again, we'll determine that as we get closer to a launch. Our focus in the near term, again, will be on healthcare provider education and awareness. We've been doing a lot of work behind the scenes on our campaigns. Now that we have data, we'll continue to work on that with our various agency partners. We're excited about that. Our focus, again, will be mostly on education and awareness for the healthcare provider community. We'll focus on bringing their key strategic positions into the organization. We'll do that methodically.
As we get closer to, hopefully, an approval and a launch, that's when we look at bringing in the sales organization. That's probably the last piece of the pie. I hope that provides you some good color in terms of what our next steps will be.
Definitely. Thanks for that, congrats again.
Thank you.
Thank you.
Thank you. We'll next go to Patrick Dolezal of LifeSci Capital.
Hi. Congrats on the data. Thank you for taking questions. The first one here, I was just curious what your current manufacturing capacity is and if this will need to be scaled up as you guys move towards commercialization.
Hi, Patrick. Our manufacturing capacity is one ton. We've been at that level for some time. Our registration batches were manufactured at that scale. We have considerable stability data that's been available for some time. We are quite confident with being able to address the commercial needs of the marketplace at this current manufacturing scale capacity. Obviously, as we continue to move on, as needed, we'll look to increase that where it warrants. We have absolutely no concerns about our manufacturing scale capacity for a commercial launch.
Great. Okay. That's helpful. Obviously, today's, well, yesterday's data were in acne, but kind of looking forward a little bit here, what's your view on the ongoing phase III program for 103 in rosacea, kind of in light of the positive data in acne? Just curious if there's any potential read-through here in terms of how the study's being conducted, mechanistic or otherwise.
Sure. As we've communicated, we've completed enrollment. We announced a few weeks back, last patient enrolled in our two phase III studies for FMX103, which is looking at a 1.5% concentration minocycline foam for the treatment of papulopustular rosacea. We remain on target to having a readout from those two phase III studies sometime in the earlier part of the fourth quarter. Regarding the read-through, as I'm sure you can appreciate, Patrick, and everyone on the call, we're always very cautious about any kind of read-through from one study to another. We're obviously, at this moment, focused on the results that we got from Study 22. Obviously, we will announce the results from the two phase III studies for 103 when they come in. What I will say in terms of where there are connections, if you will, it's the same CRO that is managing both programs.
We've communicated in the past, our CRO is Premier Research. They're out of North Carolina. They've done an excellent job for us. They're managing both programs, 101 and 103, these phase III studies. I'll just underscore again, it's the same rigor and effort regarding training from our clinical operations team being executed for the 103 studies as we've done for 101. Those are the same. Beyond that, we'll just wait for the results, and we'll let you know as soon as they come in.
Great. Super helpful. Looking forward to it. Thanks again.
The only other point I'll add to that is, that is also a sizable, meaningful market. It was the logical follow-on place for us in doing clinical development work. Rosacea after acne. As I shared before, acne continues to be a large market with unmet needs. Multi-billion-dollar category with 5 million random prescriptions a year. For the rosacea marketplace, it's about half the size, $1 billion to $1.5 billion. Unlike acne that has several players, it's got just a few products that are out there. Again, we're looking at two categories, both sizable, both large, with significant unmet needs. Our hope is that FMX103, like FMX101, will provide a meaningful solution and alternative to address those unmet needs.
Thank you. We have no further questions in the queue at this time.
Operator, any other questions?
No, sir. Not at this time. I'd like to turn the conference back over to management for any closing or additional remarks.
Well, thank you, operator. Again, thank you to everyone that's participating on this call. Appreciate you taking time out of your very busy schedules to join us. Once again, this is an exciting time for Foamix. This is a significant milestone in the history of the company. I want to, again, recognize everyone that's been involved in getting us here to this point. We look forward to providing you with additional updates on the data releases for 101 as they become available, as well as the progress for 103 and the rest of our activities. Thank you very much. Have a great day. Look forward to speaking with all of you soon. Take care.
Thank you. Ladies and gentlemen, once again, that does conclude today's conference. We thank everyone for their participation. You may now disconnect.